# Oral sucrose solution administered by a clinician two minutes before vaccination × Reduced behavioral pain and crying after vaccination Verdict 3013 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-09-07 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-21 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: The question concerns infants receiving vaccination. Hatfield concerns healthy term infants aged 2 and 4 months; Allen concerns ages 2 weeks to 18 months. Vaccine, injection counts, baseline details and detailed eligibility remain unverified by report. - Ingredient, formulation and route: The intervention is clinician-administered oral sucrose. The key positive finding concerns 24% sucrose plus a pacifier; sucking, contact, holding and breastfeeding effects are not pooled as sucrose-only analgesia. - Dose: Hatfield's 24% sucrose plus pacifier 2 minutes before vaccination is distinguished from Allen's 12% sucrose 2mL. Actual volumes, repetition, adherence and detailed amounts in other reports remain unverified. Research exposures are not converted into new use instructions. - Comparator: Hatfield's sterile water, Allen's water and no intervention, and Gad's breastfeeding and control are distinguished. Detailed balance of amounts, contact, sucking, feeding and concurrent care remains unverified. - Measured outcome: The selected question concerns behavioral pain and crying after vaccination. Hatfield's behavioral scores, Allen's crying and Gad's FLACC, crying time and heart rate are separated; pain-specific EEG and spinal reflexes during a different heel-lance procedure are not used as the same endpoints. - Duration: Hatfield concerns the context from 2 minutes before vaccination to 5, 7 and 9 minutes afterward. Measurement times, duration and actual exposure in other reports remain separately unverified. Findings are not extended to repeated routine soothing or long-term effects. - Questions outside this scope: Attributing composite behavioral signals to sucrose alone; Pooling water, no intervention, breastfeeding and different concentrations and ages as the same comparison; Extending vaccination behavioral calming to complete pain elimination or blocked neural nociception; Transferring physiological findings from separate heel lance into direct vaccination effects; Adding denominators across shared reports or creating new effects, intervals, optimal doses or repeated-use instructions ## Checklist items ### N01 · Which post-vaccination behavioral-pain and crying claim is assessed? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The selected question is reduced behavioral pain and crying after vaccination. Vaccination behavior is distinguished from pain-specific neural responses during a different procedure. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Direct material linking the relevant vaccination, intervention, comparator and behavioral endpoint is needed. Behavioral signals are not extended to complete pain elimination. - Required materials and conditions: Boundary between vaccination behavior, crying and the separate neural-response question - Materials to obtain first: Direct material linking the relevant vaccination, intervention, comparator and behavioral endpoint is needed. Behavioral signals are not extended to complete pain elimination. - Further research: Material needed: Direct material linking the relevant vaccination, intervention, comparator and behavioral endpoint is needed. Behavioral signals are not extended to complete pain elimination. This records needed materials; no new research was executed. - Conditions for verification: Original material on Boundary between vaccination behavior, crying and the separate neural-response question must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Boundary between vaccination behavior, crying and the separate neural-response question is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03, S04 ### N02 · How do selected C and parent C54 differ? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The selected behavioral-pain and crying item is C, with no individual score, status or axes. C54 is the parent account's grading context; the separate neural-response item is D. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Question-specific verdict histories and original material are needed. Parent 54 points are not filled in as the selected item's score, and existing C is not presented as a new verdict. - Required materials and conditions: Selected grade versus parent score, axes and the separate neural question - Materials to obtain first: Question-specific verdict histories and original material are needed. Parent 54 points are not filled in as the selected item's score, and existing C is not presented as a new verdict. - Further research: Material needed: Question-specific verdict histories and original material are needed. Parent 54 points are not filled in as the selected item's score, and existing C is not presented as a new verdict. This records needed materials; no new research was executed. - Conditions for verification: Original material on Selected grade versus parent score, axes and the separate neural question must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Selected grade versus parent score, axes and the separate neural question is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03, S04 ### N03 · What material was actually read in this work? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The complete stored parent Korean and English accounts, 3 evidence summaries, 4 citations and 2 subquestions were read. External papers, registration, protocols and analysis plans are unread. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Original material and actual acquisition, access and reading records are needed for each material. Historical verification narratives or bibliographic links are not promoted into current full-text reading. - Required materials and conditions: Complete stored Korean and English summaries versus external reading - Materials to obtain first: Original material and actual acquisition, access and reading records are needed for each material. Historical verification narratives or bibliographic links are not promoted into current full-text reading. - Further research: Material needed: Original material and actual acquisition, access and reading records are needed for each material. Historical verification narratives or bibliographic links are not promoted into current full-text reading. This records needed materials; no new research was executed. - Conditions for verification: Original material on Complete stored Korean and English summaries versus external reading must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Complete stored Korean and English summaries versus external reading is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03, S04 ### N04 · What comparison did Hatfield's vaccination trial make? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Hatfield 2008, PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are retained. The key comparison is 24% sucrose plus a pacifier versus sterile water. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: The original paper, registration, intervention and result material are needed. The composite is not converted into sucrose-only efficacy, and bibliography is not labeled as external full-text reading. - Required materials and conditions: Identity of sucrose-plus-pacifier versus sterile water - Materials to obtain first: The original paper, registration, intervention and result material are needed. The composite is not converted into sucrose-only efficacy, and bibliography is not labeled as external full-text reading. - Further research: Material needed: The original paper, registration, intervention and result material are needed. The composite is not converted into sucrose-only efficacy, and bibliography is not labeled as external full-text reading. This records needed materials; no new research was executed. - Conditions for verification: Original material on Identity of sucrose-plus-pacifier versus sterile water must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Identity of sucrose-plus-pacifier versus sterile water is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01 ### N05 · What was Allen's sucrose, water and no-intervention comparison? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Allen 1996, PMID8603220, DOI10.1001/archpedi.1996.02170280040007 and the randomized sucrose, water and no-intervention trial of 285 infants are retained. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: The original paper, group- and age-specific results and historical registration context are needed. The original account that registration did not exist before the registration era is not certified by a new comprehensive registry search. - Required materials and conditions: Report distinguishing age, concentration and different controls - Materials to obtain first: The original paper, group- and age-specific results and historical registration context are needed. The original account that registration did not exist before the registration era is not certified by a new comprehensive registry search. - Further research: Material needed: The original paper, group- and age-specific results and historical registration context are needed. The original account that registration did not exist before the registration era is not certified by a new comprehensive registry search. This records needed materials; no new research was executed. - Conditions for verification: Original material on Report distinguishing age, concentration and different controls must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Report distinguishing age, concentration and different controls is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S02 ### N06 · What was Gad's breastfeeding comparison? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Gad 2019, PMID30807328, DOI10.1097/NMC.0000000000000512 and the 3-arm vaccination trial of 120 infants are retained. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Original group allocation, feeding, control, vaccination conditions and endpoint-specific denominators are needed. The active comparison is not transferred to sucrose-only analgesia or a direct neural-response effect. - Required materials and conditions: Active comparison of sucrose, breastfeeding and control - Materials to obtain first: Original group allocation, feeding, control, vaccination conditions and endpoint-specific denominators are needed. The active comparison is not transferred to sucrose-only analgesia or a direct neural-response effect. - Further research: Material needed: Original group allocation, feeding, control, vaccination conditions and endpoint-specific denominators are needed. The active comparison is not transferred to sucrose-only analgesia or a direct neural-response effect. This records needed materials; no new research was executed. - Conditions for verification: Original material on Active comparison of sucrose, breastfeeding and control must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Active comparison of sucrose, breastfeeding and control is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S03 ### N07 · Does Slater's heel-lance trial answer the same question? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Slater 2010, PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 concern a separate neonatal heel-lance trial. It appears only in the stored bibliography, with no separate evidence-summary entry. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: The original paper, registration, procedure, EEG and behavioral material are needed. It is not transferred into direct replication of vaccination behavior or proof of blocked neural nociception during vaccination. - Required materials and conditions: Different procedure, pain-specific EEG and a citation-only report - Materials to obtain first: The original paper, registration, procedure, EEG and behavioral material are needed. It is not transferred into direct replication of vaccination behavior or proof of blocked neural nociception during vaccination. - Further research: Material needed: The original paper, registration, procedure, EEG and behavioral material are needed. It is not transferred into direct replication of vaccination behavior or proof of blocked neural nociception during vaccination. This records needed materials; no new research was executed. - Conditions for verification: Original material on Different procedure, pain-specific EEG and a citation-only report must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Different procedure, pain-specific EEG and a citation-only report is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S04 ### N08 · Are reports and participants counted more than once? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The selected behavioral-pain question and the separate neural question share parent reports. The 100 randomized and 83 analyzed infants, 285 infants and 120 infants are retained in their respective report contexts. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Trial flows and related report and population relationships are needed. Different denominators are not added into new participant or independent-replication totals, and heel-lance participants are not inserted into vaccination denominators. - Required materials and conditions: Shared reports, subquestions, trials and analysis denominators - Materials to obtain first: Trial flows and related report and population relationships are needed. Different denominators are not added into new participant or independent-replication totals, and heel-lance participants are not inserted into vaccination denominators. - Further research: Material needed: Trial flows and related report and population relationships are needed. Different denominators are not added into new participant or independent-replication totals, and heel-lance participants are not inserted into vaccination denominators. This records needed materials; no new research was executed. - Conditions for verification: Original material on Shared reports, subquestions, trials and analysis denominators must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Shared reports, subquestions, trials and analysis denominators is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03, S04 ### N09 · Which ages and vaccination conditions were studied? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Hatfield concerns healthy term infants, with ages 2 and 4 months in the citation title; Allen concerns ages 2 weeks to 18 months. Randomized and analyzed sample sizes are separate from eligibility criteria. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Eligibility, baseline characteristics, age, vaccine and injection counts are needed. Applicability to preterm or ill infants and other vaccination conditions remains unverified. - Required materials and conditions: Healthy term infants, age, vaccine, injection count and eligibility - Materials to obtain first: Eligibility, baseline characteristics, age, vaccine and injection counts are needed. Applicability to preterm or ill infants and other vaccination conditions remains unverified. - Further research: Material needed: Eligibility, baseline characteristics, age, vaccine and injection counts are needed. Applicability to preterm or ill infants and other vaccination conditions remains unverified. This records needed materials; no new research was executed. - Conditions for verification: Original material on Healthy term infants, age, vaccine, injection count and eligibility must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Healthy term infants, age, vaccine, injection count and eligibility is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03 ### N10 · Were concentration, volume and administration timing the same? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Hatfield used 24% sucrose plus a pacifier 2 minutes before vaccination, while Allen used 12% sucrose 2mL, as retained in the stored account. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Report-specific actual volumes, repetition, adherence, product specifications and Gad's detailed dose are needed. General administration wording is not converted into new quantitative doses. - Required materials and conditions: Reported nominal concentration versus actual exposure - Materials to obtain first: Report-specific actual volumes, repetition, adherence, product specifications and Gad's detailed dose are needed. General administration wording is not converted into new quantitative doses. - Further research: Material needed: Report-specific actual volumes, repetition, adherence, product specifications and Gad's detailed dose are needed. General administration wording is not converted into new quantitative doses. This records needed materials; no new research was executed. - Conditions for verification: Original material on Reported nominal concentration versus actual exposure must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Reported nominal concentration versus actual exposure is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03 ### N11 · Were pacifier, holding and breastfeeding effects separated? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The key positive result concerns sucrose plus a pacifier. The stored account does not attribute sucking, holding and breastfeeding effects to analgesia from sucrose alone. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Group-specific concurrent care, adherence and direct comparisons separating ingredients, sucking and contact are needed. Composite results alone do not establish the contribution of sucrose alone. - Required materials and conditions: Sweet taste, nonnutritive sucking, contact and feeding - Materials to obtain first: Group-specific concurrent care, adherence and direct comparisons separating ingredients, sucking and contact are needed. Composite results alone do not establish the contribution of sucrose alone. - Further research: Material needed: Group-specific concurrent care, adherence and direct comparisons separating ingredients, sucking and contact are needed. Composite results alone do not establish the contribution of sucrose alone. This records needed materials; no new research was executed. - Conditions for verification: Original material on Sweet taste, nonnutritive sucking, contact and feeding must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Sweet taste, nonnutritive sucking, contact and feeding is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S03 ### N12 · Are sterile water, water, no intervention and breastfeeding the same control? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Hatfield's sterile water, Allen's water and no intervention, and Gad's breastfeeding and control are different comparisons. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Actual amounts, administration, contact, sucking, feeding and concurrent care are needed for each control. The comparisons are not pooled as the same placebo. - Required materials and conditions: Actual comparisons and contact and administration conditions - Materials to obtain first: Actual amounts, administration, contact, sucking, feeding and concurrent care are needed for each control. The comparisons are not pooled as the same placebo. - Further research: Material needed: Actual amounts, administration, contact, sucking, feeding and concurrent care are needed for each control. The comparisons are not pooled as the same placebo. This records needed materials; no new research was executed. - Conditions for verification: Original material on Actual comparisons and contact and administration conditions must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Actual comparisons and contact and administration conditions is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03 ### N13 · Were randomization and blinding verified? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The stored randomized designs, Allen's double-blind description and Gad's active-control and unblinded flag are retained. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Original allocation, concealment, assessor, parent and clinician blinding and baseline-balance material are needed. Design labels alone do not complete bias assessment. - Required materials and conditions: Allocation, concealment, assessors, expectations and measurement bias - Materials to obtain first: Original allocation, concealment, assessor, parent and clinician blinding and baseline-balance material are needed. Design labels alone do not complete bias assessment. - Further research: Material needed: Original allocation, concealment, assessor, parent and clinician blinding and baseline-balance material are needed. Design labels alone do not complete bias assessment. This records needed materials; no new research was executed. - Conditions for verification: Original material on Allocation, concealment, assessors, expectations and measurement bias must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Allocation, concealment, assessors, expectations and measurement bias is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03 ### N14 · Are behavior scores, crying, FLACC and heart rate the same outcome? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Hatfield's behavioral pain at 5, 7 and 9 minutes, Allen's crying during vaccination, and Gad's FLACC, crying-time and heart-rate endpoint list are retained separately. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Scale, crying and heart-rate methods, times and endpoint tables are needed. Behavior, crying, heart rate and EEG are not pooled as one outcome, and a list alone does not establish positive findings for all of them. - Required materials and conditions: Endpoint definitions, scales, times, primary and secondary hierarchy - Materials to obtain first: Scale, crying and heart-rate methods, times and endpoint tables are needed. Behavior, crying, heart rate and EEG are not pooled as one outcome, and a list alone does not establish positive findings for all of them. - Further research: Material needed: Scale, crying and heart-rate methods, times and endpoint tables are needed. Behavior, crying, heart rate and EEG are not pooled as one outcome, and a list alone does not establish positive findings for all of them. This records needed materials; no new research was executed. - Conditions for verification: Original material on Endpoint definitions, scales, times, primary and secondary hierarchy must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Endpoint definitions, scales, times, primary and secondary hierarchy is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03 ### N15 · What were the time-specific results and 7-minute means? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The stored summary reports lower behavioral-pain scores with Hatfield's composite at each time, with 7-minute means of 3.8 versus 4.8. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Baseline or change definitions, scale units, time-specific denominators, variability, exact P values and CIs are needed. New differences or intervals are not calculated from the given means. - Required materials and conditions: Time-specific composite results, denominators and precision - Materials to obtain first: Baseline or change definitions, scale units, time-specific denominators, variability, exact P values and CIs are needed. New differences or intervals are not calculated from the given means. - Further research: Material needed: Baseline or change definitions, scale units, time-specific denominators, variability, exact P values and CIs are needed. New differences or intervals are not calculated from the given means. This records needed materials; no new research was executed. - Conditions for verification: Original material on Time-specific composite results, denominators and precision must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Time-specific composite results, denominators and precision is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01 ### N16 · How do randomized, analyzed and excluded infant counts differ? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Hatfield's 100 randomized and 83 analyzed infants, 38 versus 45, and the parent account's 17 analysis exclusions are retained unchanged. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Group-specific allocation, measurement, exclusion reasons, denominators, ITT, PP and sensitivity material are needed. Randomized counts do not replace analysis denominators, and no new exclusion rate is calculated. - Required materials and conditions: Original allocation versus group- and endpoint-specific analysis and missingness - Materials to obtain first: Group-specific allocation, measurement, exclusion reasons, denominators, ITT, PP and sensitivity material are needed. Randomized counts do not replace analysis denominators, and no new exclusion rate is calculated. - Further research: Material needed: Group-specific allocation, measurement, exclusion reasons, denominators, ITT, PP and sensitivity material are needed. Randomized counts do not replace analysis denominators, and no new exclusion rate is calculated. This records needed materials; no new research was executed. - Conditions for verification: Original material on Original allocation versus group- and endpoint-specific analysis and missingness must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Original allocation versus group- and endpoint-specific analysis and missingness is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01 ### N17 · Was the lack of a sucrose-specific advantage over water also retained? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Allen's original result is retained: at 2 weeks, sucrose and water both reduced crying versus no intervention, without a sucrose-specific effect. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Original age- and group-specific results, denominators, intervals and prespecified plans are needed. This is not converted into effect 0 at every age or concentration, or precise equivalence with water. - Required materials and conditions: Age-specific water and no-intervention comparisons and uncertainty - Materials to obtain first: Original age- and group-specific results, denominators, intervals and prespecified plans are needed. This is not converted into effect 0 at every age or concentration, or precise equivalence with water. - Further research: Material needed: Original age- and group-specific results, denominators, intervals and prespecified plans are needed. This is not converted into effect 0 at every age or concentration, or precise equivalence with water. This records needed materials; no new research was executed. - Conditions for verification: Original material on Age-specific water and no-intervention comparisons and uncertainty must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Age-specific water and no-intervention comparisons and uncertainty is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S02 ### N18 · Which endpoints showed breastfeeding superiority? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The stored account reports that breastfeeding was superior to sucrose and control for pain and crying in the 120-infant trial, with P<.001. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Endpoint-specific effects, CIs, group denominators, feeding and control conditions and heart-rate results are needed. Breastfeeding superiority is not absorbed into sucrose-only efficacy. - Required materials and conditions: Pain and crying versus separate heart-rate findings - Materials to obtain first: Endpoint-specific effects, CIs, group denominators, feeding and control conditions and heart-rate results are needed. Breastfeeding superiority is not absorbed into sucrose-only efficacy. - Further research: Material needed: Endpoint-specific effects, CIs, group denominators, feeding and control conditions and heart-rate results are needed. Breastfeeding superiority is not absorbed into sucrose-only efficacy. This records needed materials; no new research was executed. - Conditions for verification: Original material on Pain and crying versus separate heart-rate findings must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Pain and crying versus separate heart-rate findings is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S03 ### N19 · Were registration, prespecified endpoints and multiple times verified? Verification status: Unverified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Hatfield's NCT00150189, Gad's unverified registration and Allen's pre-registration-era narrative are retained. Current registration and plan material are unread. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Registration changes, protocols, analysis plans and complete results are needed. An identifier alone does not establish prespecified primary endpoints, multiplicity handling or agreement with the plan. - Required materials and conditions: Registration history, protocol, analysis plan and endpoint hierarchy - Materials to obtain first: Registration changes, protocols, analysis plans and complete results are needed. An identifier alone does not establish prespecified primary endpoints, multiplicity handling or agreement with the plan. - Further research: Material needed: Registration changes, protocols, analysis plans and complete results are needed. An identifier alone does not establish prespecified primary endpoints, multiplicity handling or agreement with the plan. This records needed materials; no new research was executed. - Conditions for verification: Original material on Registration history, protocol, analysis plan and endpoint hierarchy must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Registration history, protocol, analysis plan and endpoint hierarchy is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03 ### N20 · Can findings be generalized across concentration, age and repeated use? Verification status: Unverified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The stored account does not establish sucrose-only efficacy or an optimal dose because concentration, age, injection counts and simultaneous pacifier use differ. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Direct concentration, age, injection-count, repeated-use and subgroup material are needed. Cross-trial comparisons do not newly determine an optimal dose, effects in all infants or long-term effects. - Required materials and conditions: Direct concentration, population, injection count, repetition and durability - Materials to obtain first: Direct concentration, age, injection-count, repeated-use and subgroup material are needed. Cross-trial comparisons do not newly determine an optimal dose, effects in all infants or long-term effects. - Further research: Material needed: Direct concentration, age, injection-count, repeated-use and subgroup material are needed. Cross-trial comparisons do not newly determine an optimal dose, effects in all infants or long-term effects. This records needed materials; no new research was executed. - Conditions for verification: Original material on Direct concentration, population, injection count, repetition and durability must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Direct concentration, population, injection count, repetition and durability is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03 ### N21 · Does behavioral calming mean reduced pain-specific neural responses? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The stored account distinguishes less visible pain behavior from reduced neural nociception. The null EEG primary endpoint during separate heel lance is retained separately. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Direct material linking behavioral, neural and physiological outcomes within the same procedure is needed. Positive vaccination behavior is not transferred into complete nociceptive blockade, and null findings from another procedure do not erase behavioral reports. - Required materials and conditions: Vaccination behavior versus separate heel-lance EEG and spinal reflexes - Materials to obtain first: Direct material linking behavioral, neural and physiological outcomes within the same procedure is needed. Positive vaccination behavior is not transferred into complete nociceptive blockade, and null findings from another procedure do not erase behavioral reports. - Further research: Material needed: Direct material linking behavioral, neural and physiological outcomes within the same procedure is needed. Positive vaccination behavior is not transferred into complete nociceptive blockade, and null findings from another procedure do not erase behavioral reports. This records needed materials; no new research was executed. - Conditions for verification: Original material on Vaccination behavior versus separate heel-lance EEG and spinal reflexes must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Vaccination behavior versus separate heel-lance EEG and spinal reflexes is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03, S04 ### N22 · What funding, product support and interests were verified? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Hatfield's non-U.S. government-support indexing and no-manufacturer-involvement narrative, and Allen's and Gad's unverified specific funding and COI, are retained at the stored-account level. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Original funding, product provision, employment and COI disclosures are needed. Indexing or manufacturer narratives are not extended into absence of all interests, absence of bias or current independence certification. - Required materials and conditions: Support indexing, manufacturers, products, employment and COI - Materials to obtain first: Original funding, product provision, employment and COI disclosures are needed. Indexing or manufacturer narratives are not extended into absence of all interests, absence of bias or current independence certification. - Further research: Material needed: Original funding, product provision, employment and COI disclosures are needed. Indexing or manufacturer narratives are not extended into absence of all interests, absence of bias or current independence certification. This records needed materials; no new research was executed. - Conditions for verification: Original material on Support indexing, manufacturers, products, employment and COI must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Support indexing, manufacturers, products, employment and COI is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03 ### N23 · Are harm events and exposure denominators known? Verification status: Unverified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original caution and clinician-administered small amounts at a specified concentration are retained. The original caution concerning infants at aspiration risk is also retained. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Trial-specific events, collection methods, withdrawals, group exposure denominators and observation periods are needed. Less visible behavior is not judged as safety or absence of harms. - Required materials and conditions: Aspiration and other events, collection, withdrawal, exposure and time - Materials to obtain first: Trial-specific events, collection methods, withdrawals, group exposure denominators and observation periods are needed. Less visible behavior is not judged as safety or absence of harms. - Further research: Material needed: Trial-specific events, collection methods, withdrawals, group exposure denominators and observation periods are needed. Less visible behavior is not judged as safety or absence of harms. This records needed materials; no new research was executed. - Conditions for verification: Original material on Aspiration and other events, collection, withdrawal, exposure and time must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Aspiration and other events, collection, withdrawal, exposure and time is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03 ### N24 · What about vulnerable groups, repeated or long-term harms and use instructions? Verification status: Unverified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The account's restriction against improvised concentrations or repeated routine soothing and its clinician context are retained. This evidence table creates no new use, administration or individual-care instructions. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Group exposures, concurrent care, baseline risks, withdrawal, recovery, repeated and long-term event material are needed. Absence of rare harms, ingredient causality, comparative risks or new incidence rates is not established. - Required materials and conditions: Comparative exposure, concurrent care, baseline risks, timing and repetition - Materials to obtain first: Group exposures, concurrent care, baseline risks, withdrawal, recovery, repeated and long-term event material are needed. Absence of rare harms, ingredient causality, comparative risks or new incidence rates is not established. - Further research: Material needed: Group exposures, concurrent care, baseline risks, withdrawal, recovery, repeated and long-term event material are needed. Absence of rare harms, ingredient causality, comparative risks or new incidence rates is not established. This records needed materials; no new research was executed. - Conditions for verification: Original material on Comparative exposure, concurrent care, baseline risks, timing and repetition must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Comparative exposure, concurrent care, baseline risks, timing and repetition is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03 ### N25 · What records do the grades, languages, axes and evidence date represent? Verification status: Partly verified Reading scope: Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Selected C and absent individual score and axes, parent C54, original Korean and English accounts, axes and evidence date 2026-09-07 are retained. The original correction list and separate deliberation record are empty. - Why unverified: This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence. - Reason for missing information: Question-specific verdicts, changes and additional material are needed. Historical cross-checks and parent axes are not inherited as current completed review or new axes for the selected item. - Required materials and conditions: Selected grade versus parent context, original dates and empty change records - Materials to obtain first: Question-specific verdicts, changes and additional material are needed. Historical cross-checks and parent axes are not inherited as current completed review or new axes for the selected item. - Further research: Material needed: Question-specific verdicts, changes and additional material are needed. Historical cross-checks and parent axes are not inherited as current completed review or new axes for the selected item. This records needed materials; no new research was executed. - Conditions for verification: Original material on Selected grade versus parent context, original dates and empty change records must link to the relevant vaccination, intervention, comparator, endpoint, time and denominators, distinguishing separate heel-lance neural responses, parent context and unread external material. - Why this condition is needed: Material on Selected grade versus parent context, original dates and empty change records is needed to connect the selected vaccination-behavior and crying question with interventions, controls, endpoints, times, original reports, denominators and harm boundaries. - Application exceptions: Selected C and absent individual score, status and axes are retained, distinguishing parent C54 and separate neural-response D. Composite interventions, water, no intervention, breastfeeding, procedures and endpoints are separated. No new effect, CI, unique total, grade, administration or individual-care guidance is created. - Remaining uncertainty: Target effects, endpoint-specific denominators, measurement, prespecified hierarchy, bias, externally validated important differences, durability, harms, independence and overlap remain unverified. Original numbers, historical verification narratives and registration identifiers are not promoted into new calculations, completed content review or clinical certification. - Referenced methods: Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production. - Related sources: S01, S02, S03, S04 ## Evidence and sources ### S01 Hatfield LA et al. 2008 [PubMed](https://pubmed.ncbi.nlm.nih.gov/18245406/) Materials actually read: The complete stored parent Korean and English accounts and bibliography were read. External papers, registration, protocols, analysis plans and support disclosures are unread. Findings recorded in the summary: 100 infants randomized and 83 analyzed, 38 versus 45. Behavioral-pain scores with 24% sucrose plus a pacifier were lower at 5, 7 and 9 minutes; 7-minute means were 3.8 versus 4.8. The account's 17 analysis exclusions are also retained. Record level: These are stored composite-intervention findings. Original group allocation, exclusion reasons, time-specific variability, denominators and original CIs remain unverified. They are not promoted into sucrose-only contribution, complete nociceptive blockade or current independence certification. Independent replication: The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are linked to the original bibliography. The empty original registration field is distinguished from the citation identifier; registration, plans and full text are unread. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | External paper | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are linked to the original bibliography. The empty original registration field is distinguished from the citation identifier; registration, plans and full text are unread. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are linked to the original bibliography. The empty original registration field is distinguished from the citation identifier; registration, plans and full text are unread. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are linked to the original bibliography. The empty original registration field is distinguished from the citation identifier; registration, plans and full text are unread. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are linked to the original bibliography. The empty original registration field is distinguished from the citation identifier; registration, plans and full text are unread. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Funding, product support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID18245406, DOI10.1542/peds.2006-3719 and NCT00150189 are linked to the original bibliography. The empty original registration field is distinguished from the citation identifier; registration, plans and full text are unread. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | ### S02 Allen KD et al. 1996 [PubMed](https://pubmed.ncbi.nlm.nih.gov/8603220/) Materials actually read: The complete stored parent Korean and English accounts and bibliography were read. External papers, registration, protocols, analysis plans and support disclosures are unread. Findings recorded in the summary: 285 infants aged 2 weeks to 18 months. The original account reports that 12% sucrose 2mL and water both reduced crying versus no intervention at 2 weeks, without a sucrose-specific effect. Record level: These are stored findings specific to age, concentration and controls. They are not converted into effect 0 at every age or precise equivalence with water. Unverified funding and COI, and the pre-registration-era narrative, are not promoted into current searches or certification. Independent replication: The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | PMID8603220 and DOI10.1001/archpedi.1996.02170280040007 are retained. The pre-registration-era account is an original narrative; empty registration fields are not replaced with a new number, search or not-applicable judgment. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | External paper | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID8603220 and DOI10.1001/archpedi.1996.02170280040007 are retained. The pre-registration-era account is an original narrative; empty registration fields are not replaced with a new number, search or not-applicable judgment. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID8603220 and DOI10.1001/archpedi.1996.02170280040007 are retained. The pre-registration-era account is an original narrative; empty registration fields are not replaced with a new number, search or not-applicable judgment. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID8603220 and DOI10.1001/archpedi.1996.02170280040007 are retained. The pre-registration-era account is an original narrative; empty registration fields are not replaced with a new number, search or not-applicable judgment. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID8603220 and DOI10.1001/archpedi.1996.02170280040007 are retained. The pre-registration-era account is an original narrative; empty registration fields are not replaced with a new number, search or not-applicable judgment. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Funding, product support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID8603220 and DOI10.1001/archpedi.1996.02170280040007 are retained. The pre-registration-era account is an original narrative; empty registration fields are not replaced with a new number, search or not-applicable judgment. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | ### S03 Gad RF et al. 2019 [PubMed](https://pubmed.ncbi.nlm.nih.gov/30807328/) Materials actually read: The complete stored parent Korean and English accounts and bibliography were read. External papers, registration, protocols, analysis plans and support disclosures are unread. Findings recorded in the summary: The stored account reports that breastfeeding was superior to sucrose and control for pain and crying in a trial of 120 infants, with P<.001. Record level: FLACC, crying time and heart rate are the original endpoint list. Individual heart-rate findings, group denominators, exact effects and CIs remain unverified. Breastfeeding superiority is not transferred to sucrose-only effects or reduced neural responses. Independent replication: The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | PMID30807328 and DOI10.1097/NMC.0000000000000512 are retained. Unverified registration, funding and COI and the unblinded flag are retained without promotion into current independence or efficacy certification. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | External paper | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID30807328 and DOI10.1097/NMC.0000000000000512 are retained. Unverified registration, funding and COI and the unblinded flag are retained without promotion into current independence or efficacy certification. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID30807328 and DOI10.1097/NMC.0000000000000512 are retained. Unverified registration, funding and COI and the unblinded flag are retained without promotion into current independence or efficacy certification. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID30807328 and DOI10.1097/NMC.0000000000000512 are retained. Unverified registration, funding and COI and the unblinded flag are retained without promotion into current independence or efficacy certification. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID30807328 and DOI10.1097/NMC.0000000000000512 are retained. Unverified registration, funding and COI and the unblinded flag are retained without promotion into current independence or efficacy certification. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Funding, product support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID30807328 and DOI10.1097/NMC.0000000000000512 are retained. Unverified registration, funding and COI and the unblinded flag are retained without promotion into current independence or efficacy certification. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | ### S04 Slater R et al. 2010 [PubMed](https://pubmed.ncbi.nlm.nih.gov/20817247/) Materials actually read: The complete stored parent Korean and English accounts and bibliography were read. External papers, registration, protocols, analysis plans and support disclosures are unread. Findings recorded in the summary: The parent account distinguishes the null prespecified pain-specific EEG primary endpoint during separate heel lance from behavioral-score differences and spinal reflexes. There is no separate entry in the stored evidence-summary list. Record level: This is stored context from another procedure and endpoint. Exact concentration, volume, timing, sample size and quantitative neural findings are unlinked. Vaccination doses, ages and denominators are not transferred to this trial, and it is not counted as direct replication of vaccination behavior. Independent replication: The behavioral-pain and crying question and the separate neural-response question share parent reports. Vaccination interventions, controls, ages and denominators are distinguished from separate heel lance. Report slots and family links are not added into new unique trial, participant or independent-replication counts; those totals remain unverified. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 appear in the original citation. Citation-only status and the empty original registration field are retained; no new evidence-summary entry or direct vaccination evidence is created. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | External paper | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 appear in the original citation. Citation-only status and the empty original registration field are retained; no new evidence-summary entry or direct vaccination evidence is created. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 appear in the original citation. Citation-only status and the empty original registration field are retained; no new evidence-summary entry or direct vaccination evidence is created. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 appear in the original citation. Citation-only status and the empty original registration field are retained; no new evidence-summary entry or direct vaccination evidence is created. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 appear in the original citation. Citation-only status and the empty original registration field are retained; no new evidence-summary entry or direct vaccination evidence is created. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | | Funding, product support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID20817247, DOI10.1016/S0140-6736(10)61303-7 and ISRCTN78390996 appear in the original citation. Citation-only status and the empty original registration field are retained; no new evidence-summary entry or direct vaccination evidence is created. The material-level 2026-09-07 date is the stored account's historical evidence date. Dates originally displayed even for unread external materials are retained without conversion into external acquisition, access or reading dates, or current completed-review dates. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. ## What the statuses mean - Partly verified: Partial information from the stored summary is linked; detailed originals and content review remain incomplete. - Unverified: Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety. - Review incomplete: Review of existing content remains incomplete. - Met: This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work. - Not reported: Unreported within material actually read. Unread external material is not relabeled as unreported. - Inaccessible: This means actual access failure. External access was not attempted in this work, so this state was not assigned. - Not applicable: Used only with an application exception and reason based on the question scope. - Conflicting data: This requires actual comparison of materials; no new conflict judgment was made in this work. - Insufficient evidence for the conditions: This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade. ## Change history 2026-10-21 · Public page/materials 1.0. Public-facing views and materials were prepared from the existing 25 items. No new clinical search, verification-status change or scoring was performed.